Bladder EpiCheck Product Development Study

Nucleix Ltd.1,000 enrolled

Overview

This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance. This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Suspicion of Bladder Cancer NMIBC Surveillance

Interventions

Bladder EpiCheckDIAGNOSTIC_TEST

Methylation biomarker urine test

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 22 or older 2. Willing and able to sign the informed consent form 3. Subject(s) that is planned to undergo ,within 60 days, one of the following procedures: 3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance Exclusion Criteria: 1. Patients with known or history of muscle invasive bladder cancer (MIBC) 2. Treatment of prostate cancer or RCC in the past 2 years 3. Patients previously enrolled into this study within the prior 60 days

Locations (2)

Om Research LLC

San Diego, California, United States

RECRUITING

Chesapeake Urology Research Associates

Towson, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study.

The primary objective of the study is to support the Bladder EpiCheck product development studies. There is no measurable endpoint for this study. For each product development protocol a pre-specified primary endpoint will be defined in a dedicated SAP. For example, validation of a new PCR platform will assess the rate of agreement between the approved PCR platform and the new new platform.

Time frame: 1 year

Central Contacts

Limor Klein, PhD

CONTACT

+972-8-9161616 limor.k@nucleix.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.